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AMD Medicom Inc. recalls MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040

Recalled November 27, 2019 · FDA recall Z-0494-2020 · AMD Medicom

Hazard
Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower protection level than intended. · FDA Class II
Units
756 cases (500 units/case)
Sold at
The products were distributed tot he following US states: CA, FL, IA, IN, MD, MI, NV, NY, PA, SC, TN, TX, and WA. The products were distributed to the following foreign countries: Canada.

Description

Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower protection level than intended.

Product
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040
Manufacturer(s)
AMD Medicom Inc.
Made in
Canada

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

AMD Medicom Inc. recalls MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040 | RecallWatchUSA